Sobi exercises opt-in right for Alprolix®

Swedish Orphan Biovitrum AB (publ) (Sobi) (STO: SOBI) announced today that the company has decided to exercise its opt-in right to take over final development and commercialisation of Alprolix (rFIXFc) for the territory composed of Europe, North Africa, Russia and certain Middle Eastern markets. Alprolix is a recombinant factor IX Fc fusion protein product candidate for the treatment of haemophilia B. Sobi will make a payment to Biogen of USD 10 million, which will be held in escrow pending the EU regulatory approval of Alprolix. 

"This is an important milestone for Sobi and the result of a strong collaboration between Sobi and Biogen," said Geoffrey McDonough, CEO at Sobi. "We are looking forward to the possibility of making this innovative treatment available for people with haemophilia B upon approval in our territory, increasing treatment choices and advancing patient care for the haemophilia community."

Sobi and Biogen are collaboration partners in the development and commercialisation of Alprolix for haemophilia B. Sobi has an opt-in right to assume final development and commercialisation of Alprolix for the Sobi territory. Biogen has led development for Alprolix, has manufacturing rights, and has commercialisation rights in North America and all other regions in the world excluding the Sobi territory.

On 26 June 2015 Sobi and Biogen announced that the European Medicines Agency (EMA) had validated the Marketing Authorisation Application (MAA) for Alprolix. The validation of the MAA initiated the EMA's review process.  Alprolix [Coagulation Factor IX (Recombinant), Fc Fusion Protein] is approved for the treatment of haemophilia B in the U.S., Canada, Australia, and Japan.

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About Haemophilia B

The World Federation of Hemophilia global survey conducted in 2013 estimates that approximately 28,430 people are currently diagnosed with haemophilia B worldwide. It is caused by having substantially reduced or no factor IX activity, which is needed for normal blood clotting. People with haemophilia B experience bleeding episodes that cause pain, irreversible joint damage, and life-threatening haemorrhages. Prophylactic infusions of factor IX temporarily replace clotting factors necessary to control bleeding and prevent new bleeding episodes.